Genetically Modified Organisms - Food and Feed
Assessment of the genetically modified cotton 281-24-236 X 3006-210-23 under EU Regulation 1829/2003/EC on genetically modified food and feed (renewal application EFSA-GMO-RX-019)
Report no: 2023:03
The Norwegian Scientific Committee for Food and Environment (VKM) has assessed a renewal application for approval of the genetically modified cotton 281-24-236 X 3006-210-23for food and feed uses, import and processing in the European Economic Area (EEA).
In accordance with an assignment specified by the Norwegian Food Safety Authority (NFSA) and the Norwegian Environment Agency (NEA), VKM assesses whether genetically modified organisms (GMOs) intended for the European market can pose risks to human or animal health, or the environment in Norway. VKM assesses the scientific documentation regarding GMO applications seeking approval for use of GMOs as food and feed, processing, or cultivation.
The EU Regulation 1829/2003/EC (Regulation) covers living GMOs that fall under the Norwegian Gene Technology Act, as well as processed food and feed from GMOs (dead material) that fall under the Norwegian Food Act. The regulation is currently not part of the EEA agreement or implemented in Norwegian law.
Norway conducts its own assessments of GMO applications in preparation for the possible implementation of the Regulation.
In accordance with the assignment by NFSA and NEA, VKM assesses GMO applications during scientific consultations initiated by the European Food Safety Authority (EFSA), as well as after EFSA has published its own risk assessment of a GMO, up until EU member countries vote for or against approval in the EU Commission.
Genetically modified cotton 281-24-236 X 3006-210-23
Cotton 281-24-236 x 3006-210-23 was produced by conventional crossing of the genetically modified cotton varieties 281-24-236 and 3006-210-23. The crossed hybrid expresses the genes cry1F and pat from cotton 281-24-236, and cry1Ac and pat from cotton 3006-210-23. The genes encode the proteins Cry1F, Cry1Ac and PAT (phosphinotricin acetyltransferase).
Cry1F and Cry1Ac confer resistance to certain Lepidopteran (order of butterflies) insect pests while the PAT protein, used as a selection marker during development, increases plant tolerance to the herbicide glufosinate-ammonium.
The scientific documentation provided by the applicant is adequate for risk assessment, and in accordance with the EFSA guidance on risk assessment of genetically modified plants for use in food or feed. The VKM GMO panel does not consider the introduced modifications in cotton 281-24-236 x 3006-210-23 to imply potential specific health or environmental risks in Norway, compared to EU-countries. The EFSA scientific opinion is adequate also for Norwegian considerations. Therefore, a full risk assessment of cotton 281-24-236 x 3006-210-23 was not performed by the VKM GMO Panel.
About the assignment
The assignment is divided into three stages.
In stage 1, VKM shall assess the health and environmental risks of the genetically modified organism and derived products in connection with the EFSA scientific consultation of GMO applications. VKM shall review the scientific documentation that the applicant has submitted and possibly provide comments to EFSA. VKM must also consider: i) whether there are specific Norwegian conditions that could give other risks in Norway than those mentioned in the application, ii) whether the Norwegian diet presents a different health risk for the Norwegian population should the GMO be approved, compared to the European population, and iii) risks associated with co-existence with conventional and/or ecologic production of plants for GMOs seeking approval for cultivation. Relevant measures to ensure co-existence must also be considered.
In stage 2, VKM shall assess whether comments from Norway have been satisfactorily answered by EFSA. In addition, VKM shall assess whether comments from other countries imply need for further follow-up. If EFSAs response to Norwegian comments is not satisfactory, or comments by other countries imply the need for further follow-up, VKM shall in stage 3 perform a risk assessment of these conditions, including conditions specific to Norway.